An affordable eQMS platform

Scales from a few users to 2000+

Document-Controls
Document controls

Document controls

Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.

Version control

Change management

Audit trails

Configurable approval workflows

Metadata indexing

Integrated e-signatures (FDA 21 CFR Part 11 compliant)

Design-Controls
Design controls-icon-1

Design controls

Gather and control your design inputs and outputs in one place, stage gate your processes to continually validate designs and manage risk. Automate and bulletproof your design documentation for frictionless compliance:

Flexible phase gating

Design validation

Assemble FDA technical documentation in real-time (DHF, DHR, DMR)

Quality-Modules
Quality modules

Quality modules

A configurable suite of features to manage your quality processes to drive continuous improvement and seamless regulatory compliance:

Training matrices

Complaints handling

Non-conformance reports

CAPA forms

Post market surveillance

Compliance
Compliance

Compliance

All the tools you need to gain ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, but flexible and configurable. Cognidox helps compliance become the ‘way you do things’.

Assemble required technical documentation in real-time

Publish DHF, DHR and DMR on demand

Integrate FDA compliant E-signatures

CAPA reporting built around the way you work

Software validation

Document management software tailored to your business

Providing improved visibility and control for the development process for Semiconductors and medical device businesses.

Medical Devices

A flexible eQMS platform designed for your medical device development or IVDR compliance. Validated for ISO 13485 with quality modules, eSignatures and training matrixes built in.

High Tech Products

Our Lean DMS brings you centralised control and oversight. It ensures your product development process is consistent, sustainable, and continually improving.

Med Dev Consultants

A single platform on which you can provide unlimited clients with their own individual eQMS. You can clone a QMS structure and templates to have your clients set up in minutes.

Cognidox delivers from day one

Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system. We’ve helped hundreds of businesses bring their documents and process under control, helping them innovate faster and repeat development success time and again.

Quick & easy to implement

Quick & easy to implement

Minimises risk-icon

Minimises risk

Cost effective

Cost effective

Don't just take our word for it!

How do we work with you?

Four steps to a better DMS:

Starting with an obligation-free demo, if we’re the right fit for you we’ll offer a 60 day free trial of our platform. When you choose us as your partner, we’ll help you migrate data and configure the platform, with a dedicated account manager to look after you as you grow.

Demo

See if Cognidox can help you by scheduling a no-obligation, tailored demo

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Live Trial

Set up a free 60 day live trial to test the solution with real users and processes

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Onboard

We’ll help you configure your system, migrate your data and train your team

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Support

A dedicated Account Manager will support you as you scale (our average response time is under 20 minutes)

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Experience Cognidox

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.

Latest news & updates

Data integrity in life sciences: the vital role of ALCOA principles

Data integrity is central to the safe development and manufacturing of every life-science product ...

ISO 13485:2016: What does it take to meet medical device QMS requirements?

Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements ...

Medical Device Technical File requirements: what you need to know

What is the medical device technical file? What should it contain and how should it be structured? ...

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